Full Press Release Details
Commences Phase III Clinical Trials for COVID-19 Vaccine
BEIJING, China, September 22, 2020
--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the
"Company"), a leading provider of biopharmaceutical products in China, announced today that it has recently
commenced phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences
(Sinovac LS), or "CoronaVac," in Turkey. The phase III clinical trial seeks to test efficacy and safety of
CoronaVac in Turkey and aims to be a pivotal study to support the licensure of this product.
This case-driven, randomized, double-blinded
and placebo-controlled phase III clinical trial uses an adaptive design, and all participants will be enrolled in a step-by-step
basis. In the first stage, 1,300 healthcare workers between the ages of 18-59 years old will be randomly to receive two doses of
vaccine or placebo at a two-week interval. In the second stage, approximately 12,000 members of the general population between
the ages of 18-59 years old will be enrolled to receive two doses of vaccine or placebo at a two-week interval.
In recent months, the Company's Phase
I/II clinical trials of CoronaVac in adults (18 to 59 years old) and elderly volunteers (60 years old and above) were conducted
in China's Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively. The vaccine candidate appeared to be well
tolerated for different dosage and no serious vaccine-related adverse events were reported, demonstrating a good safety profile
for the vaccine candidate. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable immunogenicity
of CoronaVac. In addition to Turkey, the Company has partnered with several companies outside of China for phase III efficacy studies.
Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization
of vaccines that protect against human infectious diseases. Sinovac's product portfolio includes vaccines against enterovirus71
(EV71), hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine ("QIV"), H5N1
pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured
by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine
developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac
was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's
vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the
government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine,
pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine. Sinovac primarily sells its
vaccines in China, while also exploring growth opportunities in international markets. The Company is registering its products
in over 30 countries outside of China. For more information please see the Company's website at www.sinovac.com.
announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements.
These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of
1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates,"
"future," "intends," "plans," "believes," "estimates" and similar statements.
Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially
from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot
predict the potential results of the litigation it filed or that could be filed against it by others. Additionally, the triggering
of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price
should its rights plan have been triggered.